BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3447379 · Received November 4, 2013

    Report

    Report Number
    3004209178-2013-20178
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Report Date
    October 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 399930, LOT# V002125, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH IMPEDANCE ON ELECTRODES 9, 10, AND 11. REPROGRAMMING AND IMPEDANCE TESTING WERE PERFORMED. THE PATIENT WAS MEETING WITH A PHYSICIAN ON (B)(6)2013 TO DISCUSS POTENTIAL REPLACEMENT/REVISION/UPGRADE OPTIONS. INTERMITTENT STIMULATION AND LESS THAN 50% THERAPY RELIEF WERE REPORTED, AS WELL AS INCREASED PAIN IN BOTH LEGS DUE TO LOSS OF STIMULATION COVERAGE. IT WAS NOTED THIS WAS NOT "NEW" PAIN, BUT THE SAME CHRONIC PAIN BEING FELT AGAIN AFTER STIMULATION WAS NOT WORKING. INTERROGATION REVEALED THE BATTERY LIFE STATUS WAS "OK." THERE WERE NO KNOWN SPECIFIC EVENTS THAT MAY HAVE CAUSED THE ISSUE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS "ALIVE- NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567231 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Male